Guaranteeing the conformity of sealed pharmaceutical packaging
The conditions for validating pharmaceutical packaging are set out in European Directive 2011/62EU and Directive EN 16679. These standards propose several packaging solutions such as glueing, plastic film packaging, special folding techniques and the use of adhesive films.
In particular, standard 2011/62EU requires that :
- The design of the packaging must be validated to ensure that it is suitable for its intended use;
- The manufacturing process must be validated to ensure that the packaging is produced consistently and to the required quality standards;
- The packaging must undergo periodic inspection and testing to ensure that it remains fit for purpose.
In addition, the EN 16679 directive on good manufacturing practice for medicinal products requires that all materials and components used in the manufacture of pharmaceutical packaging meet the following criteria:
- They must be of the correct type and quality;
- They must be suitable for their intended use;
- They must be suitable for the manufacturing process;
- They must be stored and used in a way that protects them from contamination and degradation.
MGA, designer of customised machines for validating pharmaceutical packaging
MGA Technologies has developed solutions for the inspection of pharmaceutical packaging. High-performance and innovative, the equipment we offer ensures the conformity of pharmaceutical packaging.
The machines we design guarantee the integrity of your products. They detect any form of packaging anomaly such as damaged corners, tears, protruding tabs, poor seals, oil stains or other problems, etc.
MGA Technologies’ pharmaceutical packaging inspection machines incorporate sophisticated vision algorithms. They are able to detect, capture and classify complex defects, such as insufficient or broken seals. They can detect not only aesthetic defects, but also dimensional defects in packaging and overwrapping. The inspection is carried out at a very high rate and respects the sterility of the product. The machines can also incorporate leak-testing equipment to guarantee not only visual compliance, but also physical compliance to maintain product sterility.
MGA, a supplier of machines for Industry 4.0
MGA Technologies is a French company specialising in the design and manufacture of special, made-to-measure machines for Industry 4.0. MGA Technologies anticipates technological trends and integrates ecological and human issues to achieve sustainable gains in competitiveness.
Always attentive to our customers’ needs and their product and process constraints, we design and build your machines and equipment to help you move towards the industry of the future. Constantly on the lookout for innovative mechatronic and digital technologies, our teams will guide you in your choices to meet your needs.
If you have any questions, don’t hesitate to contact us. Our experts are on hand to provide you with a rapid, personalized response.
